In a comprehensive update, the European Medicines Agency (EMA) has released the latest regulatory recommendations for centrally authorized veterinary medicinal products. Veterinarians and stakeholders in the animal health sector will find these insights crucial for informed decision-making. Significant changes have been made to the summary of product characteristics (SPC) and package leaflets (PL) for numerous products, emphasizing the importance of monitoring and reporting any adverse effects observed in treated animals.
Veterinary Medicines for Canines
The June 2025 meeting saw updates to Bravecto’s SPC and PL, which now include additional warnings about gastrointestinal issues and rare neurological effects such as lethargy and convulsions in dogs. Similarly, Neptra ear drops have noted very rare instances of erythema, pain at the application site, and potential hearing issues in older dogs. Importantly, dog owners and veterinarians should monitor for signs of ocular irritation post-application as highlighted in the Osurnia updates.
Regulatory Changes for Feline Medications
Eluracat, intended for cats, has reported very common instances of hypersalivation and common issues like diarrhea and lethargy. Rare adverse events include anorexia and behavioral changes. Extreme vigilance is advised for signs of bradycardia and sedation. The inclusion of these adverse reactions in the SPC and PL will enable better patient management and care in veterinary practice.
Insights drawn from these updates underscore a strong commitment to safety and efficacy:
- Veterinary professionals must remain updated on these regulatory changes to ensure optimal animal care.
- The emphasis on rare adverse effects highlights the need for informed decision-making based on observed symptoms.
- Ensuring thorough communication with pet owners will be critical in monitoring and mitigating risks.
As the sector continues to harness advanced medicinal solutions for animal care, the EMA’s recommendations serve as a pivotal resource. Veterinarians should stay apprised of these updates to adeptly respond to potential adverse reactions and to optimize treatment strategies for companion animals. It’s imperative to foster a robust pharmacovigilance framework to enhance animal health outcomes continually. The proactive engagement by the EMA exemplifies the dynamic nature of veterinary pharmacology, ultimately benefitting the welfare of pets and livestock under veterinary supervision. Understanding and integrating these updates will facilitate better therapeutic outcomes and ensure the well-being of animals in a timely and effective manner.
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